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Lo studio clinico NCT05432297 per Neoplasie della Testa e del Collo, Inattività fisica è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Preventive Physical Activity Intervention in Head and Neck Cancer

In arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT05432297 è uno studio interventistico per Neoplasie della Testa e del Collo, Inattività fisica, attualmente in arruolamento. Avviato il 2 gennaio 2023, prevede di arruolare 80 partecipanti. Sotto la guida di Sahlgrenska University Hospital, dovrebbe concludersi entro il 1 dicembre 2031. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 29 novembre 2024.
Sommario breve
The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment
Titolo ufficiale

Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life

Condizioni
Neoplasie della Testa e del ColloInattività fisica
Altri ID dello studio
  • 01
Numero NCT
NCT05432297
Data di inizio (effettiva)
2023-01-02
Ultimo aggiornamento pubblicato
2024-11-29
Data di completamento (stimata)
2031-12
Arruolamento (previsto)
80
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Scopo principale
Prevenzione
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
SperimentalePhysical exercise intervention
The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.
Preventive Physical Exercise
Daily physical activity depending on daily condition
Nessun interventoControl
The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.
N.D.
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Objectively measured physical activity
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Up to 12 months
Subjectively measured physical activity - Saltin-Grimby
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
Up to 12 months
Subjectively measured physical activity (IPAQ)
Measured with the International Physical Activity Questionnaire
Up to 12 months
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Health related quality of life (HRQL) using the EORTC QLQ-C30
Measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) core questionnaire (c30). Consists of 30 items divided into six functional domains (Physical, Role, Cognitive, Emotional, and Social Functioning and Global Quality of life), three symptom scales (Fatigue, Pain, and Nausea/Vomiting) and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). All domains range from 0-100. For the functional domains a higher score indicates good function, while for all other domains a high score indicates a high prevalence of symtoms, i.e. worse HRQL.
Up to 5 years post radiotherapy
Health related quality of life (HRQL) using the EORTC QLQ H&N35
Measured with the EORTC QLQ Head and neck module (HN35). It consists of 35 questions regarding symptoms more specific to the head and neck cancer population, and domain scores range from 0-100, where a higher score represents the prevalence of more symtoms, i.e. worse HRQL.
Up to 5 years post radiotherapy
Trismus and jaw related symptoms
Patient Reported Outcomes (PRO) measured with Gothenburg Trismus Questionnaire (GTQ). The GTQ consists of 21 items divided into 3 domains; Jaw related problems, Eating limitations and Muscular tension and eight single items concerning facial pain, limitations in mouth opening and inabilities to function on social and working contexts. The GTQ domains range from 0-100 where 0 equals to absence of symtoms and 100 equals worst possible symptoms.
Up to 5 years post radiotherapy
Dysphagia related symtoms
PRO measured with M.D Anderson Dysphagia Inventory (MDADI). This is a cancer-specific instrument measuring dysphagia, social function and quality of life in head and neck cancer patients. It consists of 19 items in four domains; emotional, physical, functional and global quality of life. The range for each subscale is 20-100 where 100 indicates best possible swallowing, i.e. better outcome.
Up to 5 years post radiotherapy
Maximal Interincisal opening (MIO)
Jaw opening measured in millimeters
Up to 5 years post radiotherapy
Body composition
Bioelectric impedance analysis.
Up to 12 months post radiotherapy
Grip strength
Measured with the a hand dynamometer
Up to 12 months post radiotherapy
6-minute walking test
Measures total walking distance during 6 minutes.
Up to 12 months post radiotherapy
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
  • Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
  • Receiving radiohterapy (+/- chemotherapy) with curative intent

  • Surgery due to head and neck cancer
  • Previous treatment for head and neck cancer
  • Tracheostomized patients
  • Inability to perform exercise intervention
  • Inability to perform part of 6-minute walking test
  • Inability to independently fill out questionnaires in Swedish
  • Previous neurologic or neuromuscular disease
Sahlgrenska University Hospital logoSahlgrenska University Hospital
Parte responsabile dello studio
Lisa Tuomi, Investigatore principale, Principal Investigator, Sahlgrenska University Hospital
Contatti principali dello studio
Contatto: Lisa Tuomi, PhD, +46313421000, [email protected]
1 Centri dello studio in 1 paesi
Sahlgrenska University Hospital, Gothenburg, 41345, Sweden
Lisa Tuomi, Contatto
In arruolamento